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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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The overall objective of this study is to explore the glycemic index and glycemic load induced by an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free beer with a usual composition; b) an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This study includes two cross-over sub-studies recruiting healthy participants. In the first one, 10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer (RB), alcohol-free beer with almost completely eliminated maltose and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB) and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h, every 15 min, after ingestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First sub-study: Glucose beverage | Active Comparator | This intervention entails the intake of a beverage including 25 g of glucose. |
|
| First sub-study: Regular alcohol-free beer | Experimental | This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates. |
|
| First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin) | Experimental | This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 25 g of carbohydrates. |
|
| First sub-study: Alcohol-free beer with modified composition (++ maltodextrin) | Experimental | This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 25 g of carbohydrates. |
|
| Second sub-study: White bread + Water | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sub-study 1 | Other | Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin). |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Change from Baseline to 15-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 30-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 45-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 60-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 75-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 90-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 105-minutes after consumption of the beverage. | |
| Glucose | Change from Baseline to 120-minutes after consumption of the beverage. | |
| Insulin | Change from Baseline to 15-minutes after consumption of the beverage. | |
| Insulin | Change from Baseline to 30-minutes after consumption of the beverage. | |
| Insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Leptin | Change from Baseline to 60-minutes after consumption of the beverage. | |
| Leptin | Change from Baseline to 120-minutes after consumption of the beverage. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza | Zaragoza | 50009 | Spain |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.
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The investigator who prepares the beverages and the bread is not blinded but the investigator who manage the samples and is plan to analyze the results is blinded.
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water. |
|
| Second sub-study: White bread + Regular alcohol-free beer | Experimental | This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates). |
|
| Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin) | Experimental | This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 14.3 g of carbohydrates. |
|
| Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin | Experimental | This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 14.3 g of carbohydrates. |
|
| Second sub-study: Extra-White bread + Water | Active Comparator | This intervention entails the intake of white bread which provides 64.3 g (50 g + 14.3 g) of carbohydrates and water. This intervention would be the comparator in carbohydrates-equally conditions. |
|
| Sub-study 2 | Other | Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water. |
|
| Change from Baseline to 45-minutes after consumption of the beverage. |
| Insulin | Change from Baseline to 60-minutes after consumption of the beverage. |
| Insulin | Change from Baseline to 75-minutes after consumption of the beverage. |
| Insulin | Change from Baseline to 90-minutes after consumption of the beverage. |
| Insulin | Change from Baseline to 105-minutes after consumption of the beverage. |
| Insulin | Change from Baseline to 120-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 15-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 30-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 45-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 60-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 75-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 90-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 105-minutes after consumption of the beverage. |
| GLP-1 | Change from Baseline to 120-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 15-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 30-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 45-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 60-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 75-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 90-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 105-minutes after consumption of the beverage. |
| GIP | Change from Baseline to 120-minutes after consumption of the beverage. |
| Glucagon |
| Change from Baseline to 60-minutes after consumption of the beverage. |
| Glucagon | Change from Baseline to 120-minutes after consumption of the beverage. |
| Ghrelin | Change from Baseline to 60-minutes after consumption of the beverage. |
| Ghrelin | Change from Baseline to 120-minutes after consumption of the beverage. |
| Polypeptide Y | Change from Baseline to 60-minutes after consumption of the beverage. |
| Polypeptide Y | Change from Baseline to 120-minutes after consumption of the beverage. |
| Pancreatic polypeptide | Change from Baseline to 60-minutes after consumption of the beverage. |
| Pancreatic polypeptide | Change from Baseline to 120-minutes after consumption of the beverage. |
| HDL cholesterol | Change from Baseline to 60-minutes after consumption of the beverage. |
| HDL cholesterol | Change from Baseline to 120-minutes after consumption of the beverage. |
| LDL cholesterol | Change from Baseline to 60-minutes after consumption of the beverage. |
| LDL cholesterol | Change from Baseline to 120-minutes after consumption of the beverage. |
| Triglycerides | Change from Baseline to 60-minutes after consumption of the beverage. |
| Triglycerides | Change from Baseline to 120-minutes after consumption of the beverage. |